A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II

A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of NNC0385-0434 to Healthy Male Participants - Oral Formulation II

In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided by chance. Participants will receive 1 formulation for 10 days (first treatment period) and the other formulation for 5 days (second treatment period). The study will last up to 96 days. Only men can participate in this clinical study.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; High Cholesterol
• Intervention / Treatment: Drug: NNC0385-0434 G; Drug: NNC0385-0434 B; Drug: NNC0385-0434 F

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • Novo Nordisk Investigational Site
    • Los Angeles, California, United States, 90630
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 62 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male
• Aged 18-64 years (both inclusive) at the time of signing informed consent
• Body mass index between 20.0 and 32.0 kilogram per meter square (both inclusive)
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

• Known or suspected hypersensitivity to study interventions or related products
• Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening
• Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol
• Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator
• History of major surgical procedures involving the stomach potentially affecting absorption of study products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).	Drug: NNC0385-0434 G; Participants will receive oral dose of NNC0385-0434 G tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).; Drug: NNC0385-0434 B; Participants will receive oral dose of NNC0385-0434 B tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
Experimental: Sequence 2; Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).	Drug: NNC0385-0434 G; Participants will receive oral dose of NNC0385-0434 G tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).; Drug: NNC0385-0434 F; Participants will receive oral dose of NNC0385-0434 F tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
Experimental: Sequence 3; Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).	Drug: NNC0385-0434 B; Participants will receive oral dose of NNC0385-0434 B tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).; Drug: NNC0385-0434 F; Participants will receive oral dose of NNC0385-0434 F tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
Experimental: Sequence 4; Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).	Drug: NNC0385-0434 G; Participants will receive oral dose of NNC0385-0434 G tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).; Drug: NNC0385-0434 F; Participants will receive oral dose of NNC0385-0434 F tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
Experimental: Sequence 5; Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).	Drug: NNC0385-0434 G; Participants will receive oral dose of NNC0385-0434 G tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).; Drug: NNC0385-0434 B; Participants will receive oral dose of NNC0385-0434 B tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
Experimental: Sequence 6; Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).	Drug: NNC0385-0434 B; Participants will receive oral dose of NNC0385-0434 B tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).; Drug: NNC0385-0434 F; Participants will receive oral dose of NNC0385-0434 F tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval	Measured in h * nmol/L	From 0 to 24 hours after dose administration on visit 2, day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,NNC0385-0434,day10; maximum observed plasma concentration of NNC0385-0434	Measured in nmol/L	From 0 to 24 hours after dose administration on visit 2, day 10
tmax,NNC0385-0434,day10; time from dose administration to maximum observed plasma concentration of NNC0385- 0434	Measured in hours	From 0 to 24 hours after dose administration on visit 2, day 10

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: NN9501-4869; U1111-1271-3953 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No